A career at Medtronic is like no other. We're committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide!
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
A Day in the Life
Medtronic is currently searching for a Senior Supplier Quality Engineer to join our growing Affera team at the Billerica facility. You'll play a crucial role in supporting our Cardiac Ablation Solutions business unit by ensuring that our suppliers deliver high-quality parts, materials, and services and maintaining our high-quality standards.
Key Responsibilities:
Ensure suppliers deliver quality parts, materials, and services.
Qualify suppliers according to company standards.
Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.
Evaluate suppliers' internal functions to assess overall performance and provide feedback.
Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization).
Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.
Manage the Approved Supplier List, including administrative work in MAP Agile.
Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
Improve suppliers' performance and reduce escapes to manufacturing.
The job requires travel to visit suppliers within the United States and internationally.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's degree in engineering or related field
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Nice to Have:
Experience in Printed Circuit Board manufacturing and cable manufacturing (EE preferred) for the Capital/Hardware SQE position.
Experience with catheter manufacturing, polymer (extrusion, injection molding), metal precision processing, and adhesives for the Catheter/Disposable SQE position.
Medical device manufacturing industry experience, preferably ISO 13485.
Lead auditor experience.
Hands-on experience with SAP, Trackwise, Agile change management.
Ability to manage tasks and projects under tight deadlines with a sense of urgency.
Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
Engage in changes and advocate for inclusions/diversity.
